This single-arm, open label study is aimed to assess efficacy and safety of dolutegravir plus lamivudine as a switch strategy among TGW with HIV receiving suppresive antiretroviral therapy.
This is a phase IV, 48-week, prospective, open-label, and single arm study. Study population will include 50 TGW living with HIV on suppressive ART. Eligible participants will be switched to a 2DR base of DTG + 3TC once daily and follow-up period will be 48 weeks. The study timeline will consist of: * a selection period of up to 30 days, * a 48-week treatment period, * and a 4-week post-treatment follow-up period. The aim of the study will be to explore the effectiveness, safety, and acceptability of DTG + 3TC dual therapy among TGW living with HIV.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Enrolled participants will be switched to a dual therapy regimen consisting of 50-mg DTG plus 300-mg 3TC tablet (as a single pill fixed dose combination) orally administered once daily with or without food. No dose reductions, modifications in dosage, or changes in the frequency of dosing will be allowed in this study.
Hospital General de Agudos Dr. Juan A. Fernández, Infectious Diseases Division
Buenos Aires, Buenos Aires F.D., Argentina
RECRUITINGVirological efficacy
Proportion of participants with HIV-1 RNA pVL \>= 50 copies/mL at 48 weeks of treatment as per the intent-to-treat exposed (ITT-E) snapshot FDA algorithm.
Time frame: 48 weeks
Virological efficacy
Proportion of participants with HIV-1 RNA pVL \>= 50 copies/mL at week 48 as per-protocol (PP) analysis.
Time frame: 48 weeks
Virological efficacy
Proportion of participants with HIV-1 RNA pVL \>= 50 copies/mL at 24 weeks of treatment as per the ITT-E snapshot FDA algorithm.
Time frame: 24 weeks
Changes in CD4+ count
Absolute values and change from baseline in CD4+ lymphocyte count at weeks 24 and 48.
Time frame: 24 and 48 weeks
Safety - Adverse Events (including Serious Adverse Events and Adverse Events Leading to Discontinuation)
Number of participants with any AEs, SAEs, AEs by their severity grades, and AEs leading to discontinuation through 48 weeks. AE will be evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death).
Time frame: 48 weeks
Changes in lipid profile measurements
Change from baseline in serum or plasma total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides at weeks 24 and 48. Fasting blood samples will be collected to assess total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-dose assessment. Change from baseline is defined as post-dose visit value minus baseline value.
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Time frame: 24 and 48 weeks
Changes in Kidney Function measurements
Change from baseline in plasma creatinine at weeks 24 and 48. Blood samples will be collected to perform assess serum or plasma creatinine at week 24 and 48. Baseline value is defined as the latest pre-dose assessment. Change from baseline was calculated as post-dose visit value minus baseline value.
Time frame: 24 and 48 weeks
Changes in Body Weight
Change from baseline in absolute body weight and Body Mass Index (BMI) at weeks 24 and 48. Baseline value is defined as the latest pre-dose assessment.
Time frame: 24 and 48 weeks
Changes in Bone Mineral Density
Percent change from baseline in Bone Mineral Density (BMD) of the hip and lumber spine to week 48. BMD will be evaluated by dual-energy x-ray absorptiometry (DEXA) scans at study baseline and week 48.
Time frame: 48 weeks
Emerging resistance to study drugs
Number of participants with confirmed virological failure as per the protocol with observed genotypic resistance to DTG and/or 3TC.
Time frame: 48 weeks
Quality of LIfe
Change from Baseline in health-related quality of life using European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) and Patient Health Questionnaire-9 (PHQ-9) at baseline and weeks 4, 24 and 48.
Time frame: Weeks 4, 24 and 48
Treatment acceptance
Change from Baseline in HIV treatment acceptance using Treatment Satisfaction Questionnaire change version (HIVTSQc) and Chronic Treatment Acceptance questionnaire (ACCEPT) at baseline and weeks 4, 24 and 48.
Time frame: Weeks 4, 24 and 48
Treatment Adherence
Adherence using the ACTG adherence questionnaire at baseline and weeks 4, 12, 24, 36 and 48
Time frame: Weeks 4, 12, 24, 36 and 48.